A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

This study has been completed.

Sponsor:

Allergan

ClinicalTrials.gov Identifier:

NCT01830140

First Posted: April 12, 2013

Last Update Posted: May 6, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye [ Time Frame: Baseline, 6 Weeks ]

Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.

Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.

Drug: Bimatoprost 0.01%

Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.

Other Name: LUMIGAN® 0.01%

Active Comparator: Bimatoprost 0.03%

Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.

Drug: Bimatoprost 0.03%

Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.

Other Name: LUMIGAN® 0.03%

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of glaucoma or ocular hypertension

Exclusion Criteria:

Active ocular disease other than glaucoma or ocular hypertension

Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830140